Trovagene, Inc. and Strand Life Sciences Pvt Ltd., of Bangalore, India, complete their agreement for Trovagene's proprietary urine-based Human Papillomavirus (HPV) test.
SAN DIEGO, September 20, 2012 - Trovagene, Inc. (NASDAQ: TROV) and Strand Life Sciences Pvt Ltd., of Bangalore, India, completed their agreement to validate and commercialize Trovagene's proprietary urine-based Human Papillomavirus (HPV) test for clinical diagnostic and carrier screening use. Trovagene’s urine-based HPV test is designed to allow for completely non-invasive HPV carrier screening. Strand’s initial target market is an estimated population of over 450 million women between the ages 18 and 65 in India and South Asia.
HPV infection is the leading cause of cervical cancer. In India, cervical cancer is the leading cause of cancer related mortality in women. The incidence and death rate from cervical cancer are five times higher than in the US. The total cost of secondary treatment for cervical cancer is the highest of all chronic conditions, placing a significant burden on the Indian healthcare system.
"We are excited to work with Strand to validate and launch our proprietary HPV test in India and South Asia. Improved logistics, reduced costs and increased compliance can significantly increase HPV screening rates," states Antonius Schuh, Ph.D., chief executive officer of Trovagene. "This is the first milestone in our commercial strategy to make our HPV test available in key healthcare markets globally."
The accuracy of Trovagene's urine-based HPV test was demonstrated in a 320 patient study comparing Trovagene's test with a widely used competitive test that is based on a traditional cervical scraping sample. Trovagene's HPV test was found to have an analytical sensitivity and specificity of 93% and 96%, respectively, for the detection of high risk HPV strains vs. 78% and 86% for the competitive test.
"We have completed transfer of the test protocol and reagents and have initiated analytical validation in our labs," says Vijay Chandru, Ph.D., chairman and chief executive officer of Strand Life Sciences. "We intend to conduct a very thorough clinical validation program in our target population and launch a robust and well validated test. We are partnering with leading public health experts in women's health and will follow best practices in these programs.This test can make HPV screening broadly available to medically underserved patients in our region. Our goal is to provide patients with non-invasive testing options to determine their HPV risk factor and significantly improve women’s healthcare in India and South Asia."
About Strand Life Sciences Pvt Ltd.
Strand Life Sciences - "Strand" has pioneered the practice of scientific intelligence in life and health sciences. Strand's segue into the life sciences was through products and services for research biologists, chemists, and toxicologists that combine advanced visualization, predictive systems modeling, data integration and scientific context management. Over 2000 research laboratories worldwide (about 30% of global market share) are licensees of Strand's technology products as are several leading Pharmaceutical and Biotechnology companies. Strand and its partner Ganit Labs share additional 10,000 square feet of laboratory space with state of the art clinical genomics capabilities and capacity for pre-clinical toxicology assays of lead compounds.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine. Trovagene is leveraging its intellectual property in oncogene mutations via out-licensing and use of its transrenal technologies to extend oncogene mutation detection using urine as a sample. As a non-invasive and abundant sample, urine may overcome many of the cost and collection challenges associated with biopsy, as well as the volume limitations of blood.
Trovagene has a strong patent position as it relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the Securities and Exchange Commission.